Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry; Availability, 70194-70196 [2019-27520]
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<![CDATA[
70194
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–27552 Filed 12–19–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Child Care and Development
Fund (CCDF) Consumer Education
Website and Reports of Serious
Injuries and Death
Office of Child Care,
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Child Care
(OCC), Administration for Children and
Families (ACF), U.S. Department of
SUMMARY:
Health and Human Services (HHS), is
proposing a revision to an approved
information collection: ‘‘Child Care and
Development Fund (CCDF) Consumer
Education website and Reports of
Serious Injuries and Death.’’ (OMB
#0970–0473, expiration 2/29/2020).
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The revised Consumer
Education website reporting
requirement will require states and
territories to include certain information
about their state or territory policies
(related to background checks) on their
Consumer Education websites.
The existing Reporting of Serious
Injuries and Death reporting
requirement will not be modified.
There are no standard federal forms
associated with these reporting
requirements.
Respondents: The Consumer
Education website information
collection requirement applies to the 50
States, the District of Columbia, and five
Territories that receive CCDF grants.
The estimated number of provider
respondents for the Reporting of Serious
Injuries and Death information
collection requirement would be
approximately 10,000 annually.
ANNUAL BURDEN ESTIMATES
Instrument
Annual number of respondents
Consumer Education Website ........................
Reporting of Serious Injuries and Death ........
56 States and Territories ...............................
10,000 Child Care Providers ..........................
jbell on DSKJLSW7X2PROD with NOTICES
Estimated Total Annual Burden
Hours: 26,800.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Pub. L. 113–186; 42 U.S.C. 9858
et seq.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–27478 Filed 12–19–19; 8:45 am]
BILLING CODE 4184–43–P
VerDate Sep<11>2014
18:30 Dec 19, 2019
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3759]
Considerations for the Development of
Dried Plasma Products Intended for
Transfusion; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Considerations for
the Development of Dried Plasma
Products Intended for Transfusion;
Guidance for Industry.’’ The guidance
document provides recommendations
intended to assist manufacturers,
sponsors, and applicants developing
dried plasma products intended for
transfusion in order to facilitate the
availability of safe and effective dried
plasma products in the United States.
The guidance document provides
considerations for the successful
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Total number
of responses
per
respondent
1
1
Average
burden hours
per response
300
1
Annual burden
hours
16,800
10,000
development and licensing of dried
plasma products and for the approval of
devices used to manufacture dried
plasma. The guidance includes
recommendations on optimal sources of
input plasma; manufacturing and
product quality, including product
characterization; packaging and
reconstitution; clinical studies; and
device submissions. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
October 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on December 20, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
E:\FR\FM\20DEN1.SGM
20DEN1
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3759 for ‘‘Considerations for
the Development of Dried Plasma
Products Intended for Transfusion;
Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
VerDate Sep<11>2014
18:30 Dec 19, 2019
Jkt 250001
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Jenifer Stach, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Considerations for
the Development of Dried Plasma
Products Intended for Transfusion;
Guidance for Industry.’’ This guidance
provides recommendations intended to
assist manufacturers, sponsors, and
applicants developing dried plasma
products intended for transfusion in
order to facilitate the availability of safe
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
70195
and effective dried plasma products in
the United States. This guidance
provides considerations for the
successful development and licensing of
dried plasma products and for the
approval of devices used to manufacture
dried plasma. The guidance includes
recommendations on optimal sources of
input plasma; manufacturing and
product quality, including product
characterization; packaging and
reconstitution; clinical studies; and
device submissions.
Plasma is a critical component of
early transfusion therapy in the
management of traumatic hemorrhage.
Plasma can replenish various
coagulation proteins that are consumed
during the coagulopathy that may
accompany traumatic injury. Because
plasma products intended for
transfusion such as fresh frozen plasma,
plasma frozen within 24 hours after
phlebotomy, and plasma frozen within
24 hours after phlebotomy held at room
temperature up to 24 hours after
phlebotomy are stored frozen, these
products need to be thawed prior to
transfusion. This limits or prevents the
use of plasma in settings where freezers
and other support equipment are
unavailable (e.g., battlefields, remote
locations, and other austere settings),
and may lead to delayed administration.
Dried plasma (such as freeze-dried or
spray-dried plasma) offers the potential
to address these challenges by providing
a product that is stable at ambient
temperatures, and which can be rapidly
reconstituted and transfused.
In the Federal Register of October 30,
2018 (83 FR 54597), FDA announced the
availability of the draft guidance of the
same title. FDA received several
comments on the draft guidance and
those comments were considered as the
guidance was finalized. The guidance
announced in this notice finalizes the
draft guidance dated October 2018.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on considerations for
the development of dried plasma
products intended for transfusion. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 211 have been approved under
E:\FR\FM\20DEN1.SGM
20DEN1
70196
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Notices
OMB control number 0910–0139; the
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in 21 CFR
part 610 have been approved under
OMB control numbers 0910–0116,
0910–0139, and 0910–0338; the
collections of information in 21 CFR
part 630 have been approved under
OMB control number 0910–0116; the
collections of information in 21 CFR
part 640 have been approved under
OMB control number 0910–0116; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; and
the collections of information in 21 CFR
part 814 have been approved under
OMB control number 0910–0231.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics or
https://www.regulations.gov.
Dated: December 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27520 Filed 12–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4964]
Demonstrating Substantial Evidence of
Effectiveness for Human Drug and
Biological Products; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Demonstrating Substantial Evidence of
Effectiveness for Human Drug and
Biological Products.’’ This guidance
complements and expands on the 1998
guidance entitled ‘‘Providing Clinical
Evidence of Effectiveness for Human
Drug and Biological Products’’ (the 1998
guidance). Although FDA’s evidentiary
standard for effectiveness has not
changed since 1998, the evolution of
drug development and science has led
to changes in the types of drug
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:30 Dec 19, 2019
Jkt 250001
development programs submitted to the
Agency. Specifically, there are more
programs studying serious diseases
lacking effective treatment, more
programs in rare diseases, and more
programs for therapies targeted at
disease subsets. There is a need for more
Agency guidance on the flexibility in
the amount and type of evidence needed
to meet the substantial evidence
standard in these circumstances.
DATES: Submit either electronic or
written comments on the draft guidance
by February 18, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
2019–D–4964 for ‘‘Demonstrating
Substantial Evidence of Effectiveness for
Human Drug and Biological Products.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002 or
E:\FR\FM\20DEN1.SGM
20DEN1
]]>Agencies
[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Pages 70194-70196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27520]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3759]
Considerations for the Development of Dried Plasma Products
Intended for Transfusion; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Considerations for the
Development of Dried Plasma Products Intended for Transfusion; Guidance
for Industry.'' The guidance document provides recommendations intended
to assist manufacturers, sponsors, and applicants developing dried
plasma products intended for transfusion in order to facilitate the
availability of safe and effective dried plasma products in the United
States. The guidance document provides considerations for the
successful development and licensing of dried plasma products and for
the approval of devices used to manufacture dried plasma. The guidance
includes recommendations on optimal sources of input plasma;
manufacturing and product quality, including product characterization;
packaging and reconstitution; clinical studies; and device submissions.
The guidance announced in this notice finalizes the draft guidance of
the same title dated October 2018.
DATES: The announcement of the guidance is published in the Federal
Register on December 20, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to
[[Page 70195]]
the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-D-3759 for ``Considerations for the Development of Dried
Plasma Products Intended for Transfusion; Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Jenifer Stach, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Considerations for the Development of Dried Plasma Products Intended
for Transfusion; Guidance for Industry.'' This guidance provides
recommendations intended to assist manufacturers, sponsors, and
applicants developing dried plasma products intended for transfusion in
order to facilitate the availability of safe and effective dried plasma
products in the United States. This guidance provides considerations
for the successful development and licensing of dried plasma products
and for the approval of devices used to manufacture dried plasma. The
guidance includes recommendations on optimal sources of input plasma;
manufacturing and product quality, including product characterization;
packaging and reconstitution; clinical studies; and device submissions.
Plasma is a critical component of early transfusion therapy in the
management of traumatic hemorrhage. Plasma can replenish various
coagulation proteins that are consumed during the coagulopathy that may
accompany traumatic injury. Because plasma products intended for
transfusion such as fresh frozen plasma, plasma frozen within 24 hours
after phlebotomy, and plasma frozen within 24 hours after phlebotomy
held at room temperature up to 24 hours after phlebotomy are stored
frozen, these products need to be thawed prior to transfusion. This
limits or prevents the use of plasma in settings where freezers and
other support equipment are unavailable (e.g., battlefields, remote
locations, and other austere settings), and may lead to delayed
administration. Dried plasma (such as freeze-dried or spray-dried
plasma) offers the potential to address these challenges by providing a
product that is stable at ambient temperatures, and which can be
rapidly reconstituted and transfused.
In the Federal Register of October 30, 2018 (83 FR 54597), FDA
announced the availability of the draft guidance of the same title. FDA
received several comments on the draft guidance and those comments were
considered as the guidance was finalized. The guidance announced in
this notice finalizes the draft guidance dated October 2018.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on considerations for the development of dried
plasma products intended for transfusion. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR part 211 have been approved under
[[Page 70196]]
OMB control number 0910-0139; the collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
part 610 have been approved under OMB control numbers 0910-0116, 0910-
0139, and 0910-0338; the collections of information in 21 CFR part 630
have been approved under OMB control number 0910-0116; the collections
of information in 21 CFR part 640 have been approved under OMB control
number 0910-0116; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics or https://www.regulations.gov.
Dated: December 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27520 Filed 12-19-19; 8:45 am]
BILLING CODE 4164-01-P
